Dual Use Additives That Carry Two Regulatory Files at Once
Dual-use packaging additives demand verification against direct food additive purity and migration limits to prevent compliance failures downstream.
Regulation EU 231 2012
Meaning
A European Commission regulation defines the specific purity criteria and chemical specifications for food additives listed in the authorized European registries. This detailed standard, known as Regulation EU 231 2012, governs the allowable limits for heavy metals, moisture, and reaction by-products in additives used to formulate food-contact plastics. The rule applies directly to additive producers and compounders and is not relevant to non-food packaging or structural industrial polymers.
Purity Standard
The text sets forth limits for trace elements such as arsenic, lead, and mercury that are present in the additives. Regulation EU 231 2012 ensures that these substances do not migrate into food in hazardous quantities. Every additive substance must meet these specific chemical thresholds to be considered compliant.
Sourcing Strategy
Polymer compounders must source only those functional fillers and pigments that have been certified against these chemical specifications. This requirement restricts the use of low-grade industrial additives that contain higher levels of impurities. Suppliers of compliant pigments must furnish analytical certificates of analysis for each batch.
Quality Verification
Molding plants that produce food packaging must obtain compliance letters from their resin suppliers to verify that the colorants meet the specified purity limits. This documentation protects the molder during downstream safety audits by food brands. Sourcing certified resins prevents contamination risks in consumer packaging runs.